REFERENCE TO PROVISIONAL APPLICATIONThis application claims the benefit of U.S. Provisional Application Ser. No. 61/335,023 entitled FLEXIBLE HOSE FOR MEDICAL APPLICATIONS filed Dec. 30, 2009 by Martin E. Forrester, the disclosure of which is incorporated herein by reference.
CROSS-REFERENCE TO RELATED PARENT APPLICATIONThis application is a Continuation-In-Part of U.S. Utility patent application Ser. No. 12/354,291 entitled STRETCH HOSE filed Jan. 15, 2009 by Ralf Jourdan, the disclosure of which is incorporated herein by reference.
BACKGROUNDThe present invention relates to a flexible and easy-to-stretch hose that is crush resistant and well suited to provide a constant supply of air, anesthesia gas or gas-carried medication to a patient's face mask, nasal mask or tracheotomy tube for a variety of purposes such as anesthesia, life support or medication delivery, or to help prevent sleep apnea. Flexible, stretchable, crush resistant hoses embodying features of the invention are also well suited to evacuate gaseous pollutants from surgical areas, such as the removal of smoke during laser surgery.
Some prior crush resistant plastic hose proposals call for the use of solvents or glues to bond a web of thin material to coils of a helix that cooperate with the web to give the resulting hose its crush resistance. However, the use of solvents in the manufacture of crush resistant hoses is undesirable in medical applications because the resulting hoses may bring the patient into contact with trace amounts of the manufacturing solvent or glue, or the solvent or glue may react undesirably with medication being administered through the hose to a patient.
Some prior crush resistant plastic hose proposals intended for medical use are produced by extruding a thin web of plastic material to provide a connecting wall extending between adjacent coils of helix of plastic. This connecting web may take a wavey form or may incorporate accordion-like folds that enable the hose to extend and contract in an accordion-like manner to give the resulting hose a measure of flexibility.
Although the hoses that result from the process just described may be effective in delivering air or gas-borne substances to the patient, the nature of the extrusion process used to produce these hose products typically causes the resulting hoses to exhibit a high degree of torsional stiffness and a diminished degree of flexibility due to the orientation of the molecules that form not only the thin wavy wall but also the helix that enhances the crush resistance of the hose. The torsional stiffness can cause a patient's face mask or nasal mask to lift off the face during movements of the patient's head, thereby allowing unwanted ambient air to enter the breathing circuit during therapy. The stiff nature of existing products also may cause undesirable stress on a tracheotomy tube during patient movement, and can render difficult head movements of a patient.
DESCRIPTION OF THE DRAWINGSA fuller understanding of the invention may be had by referring to the following description, taken in conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view showing a length of flexible, stretchable, crush resistant hose embodying features of the present invention, with the hose in its normally fully contracted condition wherein radially outwardly extending portions of a thin, extruded web of plastic material that extends between coils of a crush resistant plastic helix of the hose are snugly sandwiched between adjacent side-by-side coils of the helix.
FIG. 2 is a side elevational view of the hose length, with the flexible hose in its normally fully contracted condition;
FIG. 3 is a right end view of the hose length;
FIG. 4 is a cross-sectional view, on an enlarged scale, as seen from a plane indicated by a line4-4 inFIG. 3, showing a portion of the length of flexible hose in a slightly less than fully contracted condition, with a left portion of the view illustrating how the thin, extruded web of plastic material has its opposite edge regions extending inside flat interior surfaces defined by the coils of the helix just prior to when the edge regions are welded by an application of heat energy to the flat interior surfaces of the coils of the helix, and with a right portion of the view showing how the cross-section changes once the welding or bonding of the web edge regions to the coils of the helix has taken place, causing the thin, extruded web and the coils of the helix to form an integral hose product; and,
FIG. 5 is a cross-sectional view similar toFIG. 4 but showing a portion of the length of flexible hose product in an axially extended condition.
DETAILED DESCRIPTIONReferring toFIGS. 1-3, a length of flexible, stretchable, crush resistant hose embodying features of the present invention is indicated generally by thenumeral100. Thehose100 hascoils110 of a relatively stiff plastic material that form ahelix120, and has a thin web orwall130 of plastic material that extends between thecoils110 of thehelix120.
Although thehose100 can undoubtedly be formed in a variety of ways, a preferred manufacturing technique employed during manufacture calls for the materials that form thecoils110 of thehelix120 and the thin web orwall130 to be extruded, either concurrently as separate extrusions of thehelical coils110 and the thin web orwall130 that are promptly bonded or welded together while still hot following extrusion, or as a single extrusion that forms thehelical coils110 together with an integral reach of thin web orwall130 that also is welded or bonded promptly while still hot to form thehose100.
What is referred to by use herein of the terms “welded,” “bonded,” “welding” and “bonding” is a joining together, in a heated environment or as a result of an application of heat energy (whether applied by radiation, convection, the use of laser-generated light or any other known or yet to be developed technique, or a combination thereof) of thermoplastic materials from which components of thehose100 may be formed, including but not limited to PVC, TPU, PP, TPE, ABS and other thermoplastic materials and reasonable equivalents thereof, to form what results in or amounts to an integral assembly that typically exhibits no remaining borders between adjacent portions of the bonded or welded materials. In essence, the terms “welded” and “bonded,” and the terms “welding” and “bonding” are used interchangeably, with no intended differences of meaning intended therebetween.
As depicted inFIGS. 1 and 2, the flexible, stretchable, crush-resistant hose100 is in its normally fully contracted condition (also referred to herein as its “normal condition”), with thecoils110 of thehelix120 situated side-by-side relatively snugly sandwiching radially outwardly extendingportions152 of the thin plastic web orwall130 therebetween. Thehose100 has its minimal length when it is in its normal condition as depicted inFIGS. 1 and 2, and can be stretched or extended, for example as is shown inFIG. 5, which causes thecoils110 of thehelix120 to separate, and causes the outwardly extendingportions152 of the thin web orwall130 to flatten out or “unfold,” typically in the manner depicted inFIG. 5. If, during stretching or extension, thehose100 is caused to bend or deflect (from any of the linear or straight-line configurations that are depicted inFIGS. 1,2,4 and5), the crush resistant character of thehose100 will permit the bending or deflection to take place without significantly diminishing the inner diameter (designated by thenumeral140 inFIG. 3) of thehose100.
Thecoils110 of plastic material that form thehelix120 have a uniform cross-section that preferably features a roundedexterior surface112 and a substantiallyflat interior surface114. When the substantially flatinterior surface114 is viewed from an end of the length ofhose100, as is depicted inFIG. 3, it will be seen to take the form of a circle which defines aninterior diameter140 of thehose100. These circles defined by all of thecoils110 are of substantially the same diameter.
Referring to the left “half” ofFIG. 4, the thin web orwall130 that extends between adjacent pairs of thecoils110 is preferably formed by extruding a thin, flat, elongate, tape-like or band-like web ofplastic material132 that ultimately has itsopposite edge regions134 bonded or welded to the flatinterior surfaces114 of thecoils110. As is shown somewhat schematically in the left “half” ofFIG. 4, theedge regions134 of the thin wall orweb130 each preferably extend about halfway into and along theflat interior surfaces114 of thecoils110—at which locations theedge regions134 are welded or bonded to theflat surfaces114 by an application of heat energy to form anintegral hose100, in a manner that is depicted in the right “half” ofFIG. 4.
In essence, such boundaries as exist between theedge regions134 and the flat interior surfaces114 (as depicted in the left “half” ofFIG. 4 at a time before welding or bonding takes place) effectively “disappear” as the thermoplastic materials forming thecoils110 and theweb edge regions134 merge and integrally bond during welding or bonding to form theintegral hose product100 that is shown in the right “half” ofFIG. 4.
If identical thermoplastic materials are used to form thecoils110 or thehelix120 and the thin web orwall130, thehose100 that results when a proper thermoplastic welding or bonding process has been completed is a one-piece member with no discernible borders or boundaries.
If, on the other hand, different thermoplastic materials (for example a material used to form thecoils110 of thehelix120 that has a higher modulus of elasticity than does a material used to form the thin web or wall130) are separately extruded and properly thermoplastically welded or bonded to form the hose100), the material of the web orwall130 may provide an contiguous, continuous and uninterrupted liner that shields the material of thecoils110 of thehelix120 from contact with gases and the like that flow through theinner diameter140 of thehose100—which, in certain medical applications may be of importance to prevent interactions between the material forming thecoils110 of thehelix120 and certain medications being carried by gases flowing through thehose100.
To enhance the stretchability and flexibility of thehose100 without diminishing its crush resistance, and to thereby avoid the problems of stiffness that are characteristic in many of the crush resistant hoses of prior proposals, the bonded orwelded hose product100 is subjected to an annealing process that modifies the orientation of the molecules of thermoplastic that forms thecoils110 of thehelix120 and the thin wall orweb130 that extends between thecoils110 of thehelix120.
When thehose100 initially is formed, thecoils110 of thehelix120 are relatively widely spaced, and the thin web of plastic material that extends between adjacent pairs of thecoils110 takes a cylindrical shape that does not project radially outwardly at locations between thecoils110 of thehelix120. However, as the annealing process is carried out, thecoils110 of thehelix120 are moved closer and closer toward each other, which causes theweb130 situated between adjacent pairs of thecoils110 to bulge radially outwardly, creating the radially outwardly extendingportions152. As the elements of thehose100 come to the “normal condition” depicted inFIGS. 1 and 2) wherein thecoils110 assume side-by-side positions snugly sandwiching the radially outwardly bulgingweb130 therebetween, a reverse-direction crease or fold150 (seeFIGS. 4 and 5) is caused to form and set at a central location extending along the length of the tape-like or band-like web orwall130.
As the heating and controlled cooling of the annealing process is completed with thehose100 in its minimal-length “normal condition” (as depicted inFIGS. 1 and 2), the molecules of the material of thecoils110 and the web orwall130 relax and take on a new orientation with a memory of the “normal condition” to which the completedhose100 will normally return when released from the imposition of external forces (including the force of gravity). And, because stress is substantially absent from thehose100 when thecoils110 of thehose100 are side-by-side compressing the radially extending web orwall portions152 therebetween (i.e., when thehose100 is in its “normal condition” as depicted inFIGS. 1 and 2), thehose100 begins resisting extension only when, and to the extent that, thehose100 is stretched causing it to lengthen.
Stated in another way, the annealing process to which thehose100 is subjected allows thehose100 to exhibit a greater degree of flexibility and an ease of being stretched than are exhibited by conventional, non-annealed hose products, and enables thehose100 to, in effect, provide a “strain relief” between medical delivery equipment (not shown) that typically is connected to one end region of a length of thehose100, and a patient's facial or nasal mask (not shown) that typically is connected to an opposite end region of the same length ofhose100 in medical applications that often make use of thehose100.
Yet another benefit of the annealed and stress-relieved hose100 (which results from stresses that were introduced during the manufacture of thehose100 being relieved during annealing) is that the stress-relievedhose100 does not take a set (i.e., does not take on a configurational memory to which thehose100 seeks to return) when deflected or bent in any one direction or orientation for a lengthy period of time.
When thehose100 is in its normally fully contracted condition, as is depicted inFIGS. 1 and 2, the centrally located reverse-direction crease orfold150 that is set in the thin tape-like or band-like web orwall130 is located radially outwardly beyond the roundedexterior surfaces112 of thecoils110 that form the helix120 (a feature best seen inFIG. 4). The length of the radially outwardly extendingportions152 of the web130 (that extend from theinner diameter140 of thehose100 to the reverse-direction creases orfolds150 that define the outer diameter of the hose100) provides the web orwall130 with a greater surface area to displace during flexure of the hose100 (than typically is found in present day hoses utilized to deliver air, medicinal gases and the like in today's medical environments)—which also helps to enhance the flexibility of thehose100.
A feature of thehose100 is its extensibility (i.e., the ease with which thehose100 can be stretched). The length of the radially outwardly extendingportions152 of theweb130, and the accordion-like reverse-direction crease orfold150 that extends radially outwardly of the curvedouter surfaces112 of thecoils110 of thehelix120 gives thehose100 an impressive ability to extend when a patient situated near one end of a reach of thehose100 moves relative to a medical apparatus connected to an opposite end of the reach ofhose100—which is to say that thehose100 provides a “strain relief” that minimizes the transmission of force along the length of thehose100.
What a length of thehose100 typically offers is an ability to stretch (in an example manner depicted inFIG. 5) to a length of at least about one and a half times the length that is exhibited by the hose when at rest in a normally fully contracted condition (as is depicted inFIGS. 1 and 2). This extensibility characteristic represents a significant improvement in comparison with such limited extensibility as may be offered by many present day crush resistant hoses that are being utilized to deliver gases in medical applications.
When thehose100 is extended in the manner depicted inFIG. 5, the memory of thehose100 provides a gentle spring effect that will tend to return thehose100 to its normal fully contracted condition (i.e., its “normal condition” as depicted inFIGS. 1 and 2) when the force causing the hose to extend diminishes and is released relieved. This gentle spring effect is unlike the forceful resistance to stretching or extension that often is encountered with the use of present-day crush resistant hoses in use to deliver gases in medical applications.
When thehose100 is extended (for example, in the manner depicted inFIG. 5), the radially extendingportions152 and the reverse-direction creases orfolds150 of the web orwall130 are pulled radially inwardly—but not in a way that diminishes the interior diameter140 (labeled inFIG. 3) of thehose100 that exists after theweb130 and thecoils110 of thehelix120 are bonded or welded to form the integral hose product that is depicted in the right “half” ofFIG. 4 wherein theedge regions134 shown in the left “half” ofFIG. 4 (at a time prior to bonding or welding) have become integrally bonded or welded to thecoils110 of thehelix120.
In one preferred embodiment of thehose100, the spring tension that tends to cause the hose to retract to the normal condition builds up in the hose only when the hose is stretched, and the spring tension attributable to the thermoplastic material forming the web in proportion to the spring tension attributable to the thermoplastic material forming the coils of the support spiral is at least about 25% to at least about 50%; and, in some embodiments, this ratio may be at least about 25% to as high as at least about 90%.
In one preferred embodiment of thehose100, thehelix120 and theweb130 are formed from the same thermoplastic copolyester elastomer, also known as TPC-ET. One suitable example of a TPC-ET material well suited to form thehose100 is sold by E.I. Dupont deNemours & Company under the registered trademark HYTREL—the torsional stiffness of which can be relieved by heating the weldedhose100 during an annealing process. The stress relievedhose100 that results once the annealing process is completed is of continuously wound, heat welded, thermoplastic construction, and uses no solvents or glues to bond or weld theplastic helix120 to theedge regions134 of the thin web orwall130 at locations along the flatinner surfaces114 of thecoils110 of thehelix120.
Hoses100 embodying such features as are described herein can be produced in sizes a small as 0.315 inch inside diameter, making thehose100 ideal for medical applications where lightweight, small diameter hoses are needed.
An objective of the annealing process to which thehose100 is subjected is to diminish torsional stiffness of the resulting hose. Torsional stiffness is defined as how much twisting force is transmitted through thehose100 before it “breaks away” into an arc or spiral that will absorb additional twisting force when one end is held securely to a fixed point. This could also be regarded as the “twisting yield point.”
For example, when a nurse moves a piece of life support equipment connected to a patient with a hose of high torsional stiffness, a great deal of the movement is transmitted through the hose to the patient interface, which creates a potential for the interface to leak or become disconnected from the patient. However, a hose with low torsional stiffness used in the same situation will “break away” into an arc or spiral thereby reducing the force that is transmitted to the patient interface, which is less likely to cause a face mask or the like to be moved from properly engaging the face of a patient.
The torsional stiffness of a hose can be determined quantitatively by measuring the amount of force required to cause a length of the hose of approximately five to ten times the internal diameter of the hose to “break away” from alignment with an axis that extends centrally through the hose, with one end of the hose under test being connected to a torque measuring device, and with the other end being turned in a direction opposite that of the wind of the helix of the hose. The annealing process to which thehose100 is subjected typically diminishes torsional stiffness by at least about 20 percent when compared with similar hoses presently in use in medical applications.
Ahose100 embodying features of the present invention can be formed using a two step manufacturing process. A first step is to continuously wind a molten plastic (preferably a thermoplastic copolyester elastomer) profile in the shape of both thethin wall130 and thehelix120 portions of thehose100 around a series of spinning mandrels that are angled to allow the profile to progress forwardly off of the mandrels. The angle is controlled to insure there is a sufficient bond of theedge regions134 of tape-likethin wall130 to the flat insidesurfaces114 of thecoils110 of thehelix120. The angle provides the necessary pitch of helix spacing, which is typically two to five times the final dimension of the resultinghose100 after annealing.
A second step is to anneal thehose100. This may be achieved by compressing thehose100 axially, and placing thehose100 in an oven at a temperature below the melting temperature of the plastic material that forms thehose100, for enough time 1) to relieve such stress as was introduced during the extrusion process, and 2) to cause thefold150 to be set into thethin wall130 of thehose100. Thehose100 is then removed from the oven, whereafter thehose100 is cooled and flexed to ensure that the desired degree of flexibility has been achieved.
Although a thermoplastic copolyester elastomer (TPC-ET) material such as Dupont HYTREL is a preferred material from which to form all components of thehose100, thehelix120 and theweb130 components of thehose100 may be formed from different thermoplastic materials, or from thermoplastic materials that differ from TPC-ET. Either or both of the helix and the web that connects adjacent coils of the helix may, for example, be formed from PVC, TPU, PP, TPE or ABS thermoplastic, or from any other commercially available thermoplastic polymers or blends thereof.
When the same TPC-ET material is used to form both thehelix120 and theweb130, thehelix120 and theweb130 can be extruded from a single die. TPC-ET is desirable for use in forming thehose100 when thehose100 is to be used in medical applications because the TPC-ET can be steam autoclaved to sterilize thehose100, as is desirable in medical environments.
TPC-ET material is naturally clear or translucent in thin cross-sections, such as are employed in forming theweb130 of thehose100, and becomes opaque in thicker sections such as are employed in forming thehelix120. Thus, even though the same TPC-ET material may be used to form theweb130 and thehelix120 of thehose100, the resultinghose100 will likely have the appearance of being formed from two different materials.
Alternatively, thehose100 may be formed from two different materials in order to create a totally transparent hose, or to create a two color hose, or a clear walled hose that has a specific colored helix—which may be desirable in order to to “color code” particular reaches of thehose100 so they will be consist twenty used to deliver only particular gases or gaseous mixtures to patients. Colorants can, of course, be added to any of the plastic materials used to form thehose100 to achieve practically any desired color combination.
Materials having different characteristics such as hardness can be used to form the web orwall130 and thecoils110 of thehelix120, which may involve the use of two separate extruders and either a co-extrusion die, or separate dies to create theweb130 andhelix120 separately, whereafter they are welded or bonded. Likewise, materials that have different moduli of elasticity may be used to form the web orwall130 and thecoils110 of thehelix120—with, for example, the material forming thecoils110 of thehelix120 having a higher modulus of elasticity than the material forming the web orwall130, to enhance the crush resistance of the resultinghose100.
Although the invention has been described in its preferred form with a certain degree of particularity, it is understood that the present disclosure of the preferred form has been made only by way of example, and that numerous changes in the details of construction and the manner of manufacture may be resorted to without departing from the spirit and scope of the invention. It is intended to protect whatever features of patentable novelty exist in the invention disclosed.
The claims that follow are intended to protect whatever features of patentability that exist in the invention features disclosed in the text, the drawings and the claims hereof and in the referenced provisional and parent applications, the disclosures of which are incorporated herein by reference.